Psychedelic Therapy EO Is a Major Step for Mental Health, but Access Barriers Remain, Experts Say

For decades, psychedelic medicine has occupied a complex and often contentious space between restrictive federal scheduling and emerging clinical research. However, a recent executive order (EO) signed by President Donald J. Trump has initiated a formal effort to accelerate the research, regulation, and integration of these substances into the national health care landscape.¹ The policy directs federal agencies to streamline pathways for breakthrough mental health treatments, specifically targeting the needs of the veteran community and addressing the ongoing national mental health crisis.

In recent interviews with The American Journal of Managed Care^® (AJMC^®), Brett Waters, cofounder of Reason for Hope and the Veteran Mental Health Leadership Coalition, and Scott Shannon, MD, CEO of the Board of Psychedelic Medicine and Therapies and founder of Wholeness Center in psychedelic-assisted therapy, examined the logistical shifts, professional implications, and systemic hurdles associated with this federal acceleration. Both experts suggest that while the order is a significant milestone, the transition from policy to patient access remains fraught with infrastructure and insurance challenges.

The executive order comes nearly 2 years after the FDA rejected Lykos Therapeutics’ application for MDMA-assisted therapy for posttraumatic stress disorder (PTSD),² a decision that intensified debate around psychedelic medicine and veteran mental health care.³ At the time, veteran advocates, researchers, and clinicians interviewed by AJMC emphasized both the urgent need for new PTSD treatment options and the importance of rigorous evidence and oversight. Experts, including Shannon, who was a MAPP1/2 study investigator, and Waters, an attorney and multigenerational survivor of suicide loss, argued that psychedelic-assisted therapies could offer transformative benefits for veterans with treatment-resistant PTSD, while also acknowledging concerns around access, infrastructure, ethics, and the need for continued research.

Regulatory Mechanisms and Bureaucratic Realignment

The new EO aims to address what advocates describe as a long-standing lack of centralized federal leadership in navigating the transition from clinical trials to public access. Waters characterized the order as a "jolt" intended to synchronize agency actions and provide the necessary "White House sign-off" for pending regulatory moves that had previously been stalled within the bureaucracy. Shannon added that the EO brings "serious credibility and support" to a field that has historically been stigmatized or ignored by federal leadership.

Key Administrative Directives

The EO introduces several administrative mechanisms designed to shorten the developmental timeline for these therapies by reducing bureaucratic friction:

• National Priority Vouchers: Three companies have been granted vouchers to potentially reduce FDA review timelines for breakthrough compounds, a move that could significantly accelerate the final stages of the approval process.
• Accelerated DEA Rescheduling: The order directs the Drug Enforcement Administration (DEA) to begin the rescheduling process earlier, following phase 3 trials, rather than awaiting final FDA approval.
• Time-to-Market Projections: This shift in rescheduling timing could theoretically reduce the time-to-market for breakthrough therapies by approximately 1 year.
• ARPA-H Matching Funds: The policy includes $50 million in matching funds for research and drug development.
• Funding Longevity: Advocates are currently working with other organizations to secure appropriations language for fiscal year 2027 to ensure this funding becomes an ongoing federal commitment.

Shannon noted that these steps are essential to offset the high costs of the current process. He highlighted that Lycos raised over $100 million to navigate the FDA pipeline, making it only the second medication to reach the submission stage without the backing of a major pharmaceutical corporation.

The Role of the VA System

The Department of Veterans Affairs (VA) is positioned as a primary site for the implementation of these directives. Given the high prevalence of PTSD, treatment-resistant depression, and suicide among veterans, the system faces immense pressure to adopt new care models. Shannon observed that the plight of veterans is one of the few issues that receives bipartisan support, which has played a major role in the political momentum behind psychedelic research.

Systemic Readiness and Workforce Development

Despite the high profile of the issue, the VA’s large bureaucracy presents unique challenges for rapid integration. Experts are tracking several metrics of readiness:

• Active Research Portfolio: The VA is currently involved in over 20 clinical studies related to psychedelic therapies, representing a significant internal research effort.
• Workforce Training: Approximately 250 VA practitioners have already undergone specialized training to administer these treatments.
• The Integrated Project Team (IPT): The VA has launched an IPT to prepare for potential FDA approvals, though Waters suggests more public transparency and direct funding are needed for these teams.
• Legislative Support: The VHA Novel Therapeutic Preparedness Act is under review to assist the VA in transitioning research into clinical practice more efficiently.
• Data Collection Requirements: Advocates stress the importance of developing new billing codes and longitudinal tracking to assess functional outcomes over time, rather than just immediate adverse events.

Waters expressed frustration with the historical lack of direct funding from the VA, but noted that the EO encourages better collaboration across agencies to improve the pace of resource flow.

Right to Try and the Ibogaine Framework

A distinct element of the EO is its emphasis on the Right to Try pathway, particularly as it relates to compounds like ibogaine. Currently, the landscape for ibogaine is marked by high demand but significant legal complexity; many veterans are forced to travel to international clinics in countries like Mexico to seek treatment for severe addiction and trauma, a situation Waters described as "tragic."

During a recent briefing on the EO, advocates and legal experts emphasized that congressional action will still be needed to fully implement the administration’s push to expand access to psychedelic-assisted therapies. While the order directs the FDA and DEA to establish a pathway for Schedule I psychedelics under the Right to Try Act, speakers said current conflicts with the Controlled Substances Act remain a major barrier. As a result, advocates, including Waters, argued that passage of the Freedom to Heal Act is necessary to create a formal physician registration pathway that would allow eligible patients to access investigational psychedelic therapies outside of clinical trials while maintaining DEA oversight.

Waters cautioned that the EO is not "self-executing" with respect to Right to Try. He expressed concern that the DEA’s implementation of a waiver process could be more "burdensome and bureaucratic" than existing FDA Expanded Access programs, potentially rendering the pathway unworkable for most clinics.

A Paradigm Shift: From Management to Transformation

The transition toward psychedelic medicine represents a fundamental departure from the "suppressive model" that has dominated psychiatry for 7 decades. Shannon argues that traditional care has focused on daily symptom management via neurotransmitter modulation, whereas psychedelics facilitate "transformative" changes through neuroplasticity and the processing of underlying trauma.

“I'm concerned that if we bring psychedelics to market using the same model paradigm that has existed in psychiatry for the last 70 years, with medication and a reductionistic model that focuses on neurotransmitters and doesn't really focus on context, personal experience, and transformative change, that we’ll keep ourselves trapped in an old model,” he said.

The Challenges to Clinical Integration

While the potential for "cure" is now being discussed within a field that previously only spoke of management, the path to commercialization remains complex:

• Psychotherapy Requirements: Shannon warned that the FDA, which primarily regulates pharmacology, may struggle to evaluate treatment models that necessitate "embedded psychotherapy."
• Long-Term Efficacy: Unlike standard psychiatric medications like selective serotonin reuptake inhibitors, where effects may fade after 6 to 12 weeks, Shannon noted that patients in MDMA trials often showed more improvement at 1 year than they did at 6 weeks.
• Infrastructure Demands: These therapies require specialized clinics and long-duration sessions, which do not fit into the standard 15-minute medication management window.
• Insurance Coverage: Waters highlighted that without established reimbursement rates, access will remain limited to those who can pay out-of-pocket.
• State-Level Acceleration: In the absence of federal insurance coverage, both experts predict that state-level regulatory efforts outside the FDA framework will only accelerate as patients seek affordable options.

Shannon also criticized the FDA's previous advisory panel decisions. “On the advisory panel that the FDA selected, they had 1 person out of 11 who had any psychedelic experience, knowledge, or background with it, and it’s not surprising that the vote went 10 to 1,” he said. “I think that's a real mistake.” He attributed the 2024 rejection to institutional inertia and a "mass ignorance" regarding the unique paradigm of psychedelic-assisted care.

Outlook and Success Metrics

What would "meaningful success" look like for this EO in the coming years? According to Shannon, success is measured by the return of the concept of healing to psychiatry. This involves moving patients away from a daily dosing model toward interventions that trigger long-term evolution and change.

“I think psychedelics bring a new paradigm and a new model where healing comes back into the forefront,” he said, “and we begin to understand that everybody has the capacity to heal and get better over time, and psychedelics bring that back to psychiatry.”

Waters emphasized that the immediate focus must remain on carrying out the directives of the EO to ensure they do not remain mere "public discussion." The system will require continued support for workforce development and physical infrastructure to ensure that new treatments do not result in longer wait times for other forms of care in a system that is already strained.

“I'm hoping with this executive order, we'll start to see maybe a little bit more public discussion there,” he said. “They also have an integrated project team that is supposed to be helping prepare for FDA approvals. So I’m hoping that it will be a little more public in terms of what they’re planning and researching.”

While the 2026 EO provides a significant regulatory "green light," the experts agree that it is only the beginning. The success of the policy will depend on the ability of federal agencies to cooperate, the willingness of Congress to pass clarifying legislation like the Freedom to Heal Act, and the capacity of the health care system to adapt its billing and treatment models to a new era of mental health care.

References

1. Accelerating Medical Treatments for Serious Mental Illness. Executive order. April 18, 2026. Accessed May 1, 2026. https://www.whitehouse.gov/presidential-actions/2026/04/accelerating-medical-treatments-for-serious-mental-illness/
2. Grossi G. MDMA-assisted therapy receives a complete response letter from the FDA. AJMC. August 9, 2024. Accessed May 1, 2026. https://www.ajmc.com/view/mdma-assisted-therapy-receives-a-complete-response-letter-from-the-fda
3. Grossi G. Following FDA rejection, experts discuss MDMA therapy, improving care for veterans with PTSD. AJMC. August 21, 2024. https://www.ajmc.com/view/following-fda-rejection-experts-discuss-mdma-therapy-improving-care-for-veterans-with-ptsd